Regorafenib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat gastrointestinal stromal tumors or colorectal cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe liver problems, high blood pressure, or increase your risk for bleeding. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: regorafenib, oral; Stivarga

What is this medicine used for?

This medicine is taken by mouth to treat advanced colorectal cancer that has spread to other parts of the body. It may also be used to treat gastrointestinal stromal tumors (GIST) that cannot be treated with surgery or that has spread to other parts of the body. This medicine is used when other cancer medicines have not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems
• Heart disease, heart attack, or chest pain
• High blood pressure
• Liver problems

Tell your provider if you are scheduled to have surgery.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant while taking this medicine or within 2 months of stopping treatment with this medicine, contact your healthcare provider right away. Use effective birth control during treatment with this medicine and for at least 2 months after you stop treatment. Do not breast-feed while you are taking this medicine.

Males: Use condoms during sexual intercourse with females of childbearing age while you are taking this medicine and for at least 2 months after you stop taking it.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine at the same time each day with a low-fat breakfast. Swallow the tablets whole with water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember on that day. If you do not remember until the next day, skip the missed dose and take the next one as directed. Do not take double doses or take 2 doses in the same day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: hoarseness; severe diarrhea; dry mouth; severe tiredness; skin rash, redness, swelling, or blistering.

What should I watch out for?

This medicine may cause severe or life-threatening liver problems. If you have itching, yellowing of your skin or eyes, dark urine, loss of appetite, or light-colored bowel movements, contact your healthcare provider right away.

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine increases the risk for reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you have:

• Headache
• Seizures
• Weakness
• Confusion
• Trouble seeing or changes in vision
• Problems thinking

This medicine may cause high blood pressure or increase your risk for bleeding. Check your blood pressure regularly as instructed by your healthcare provider. Use a soft brush to brush your teeth. Be careful while shaving or using sharp objects.

This medicine may cause a skin problem called hand-foot skin reaction. Contact your healthcare provider if you have redness, pain, swelling or blisters on the palms of your hands or the soles of your feet. Your dose of this medicine may need to be changed if this happens.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Unexplained bruising or bleeding; blood in the urine or bowel movements; black or tarry bowel movements; menstrual bleeding that is heavier than normal; chest pain; severe dizziness or fainting; shortness of breath; unusual sweating; unexplained tiredness or weakness; yellowing of your skin or eyes; dark urine; light colored bowel movements; unexplained loss of appetite; severe headaches; seizures; confusion; vision changes; problems thinking; severe stomach pain or swelling; severe nausea, vomiting, or diarrhea; fever; pain, redness, swelling or blisters on the palms of your hands or soles of your feet; severe rash or itchy peeling skin; wounds that won’t heal.

Other: Mouth sores; mild diarrhea; nausea; loss of appetite; voice changes or hoarseness; weight loss; joint and muscle pain or stiffness; hair loss; change in sense of taste; dry mouth.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), and tetracycline
• Antidepressants such as desipramine (Norpramin) and nefazodone
• Antifungal medicines such as clotrimazole, fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Aprepitant (Emend)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), bicalutamide (Casodex), ceritinib (Zykadia), crizotinib (Xalkori), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), irinotecan (Camptosar), mitotane (Lysodren), and nilotinib (Tasigna)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dexamethasone
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), dronedarone (Multaq), nicardipine (Cardene), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Lomitapide (Juxtapid)
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), argatroban, bivalirudin (Angiomax), clopidogrel (Plavix), dipyridamole (Persantine), eptifibatide (Integrilin), lepirudin (Refludan), tirofiban (Aggrastat), and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Simeprevir (Olysio)
• St. John's wort

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep this medicine in the bottle that it comes in and do not remove the desiccant packet inside. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Discard any unused medicine 7 weeks after you open the bottle.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.